Method and apparatus for treating pelvic organ prolapse

ABSTRACT

A method of treating pelvic organ prolapse is provided. The method generally includes the steps of establishing a first pathway between the external perirectal region of the patient to the region of the ischial spine in tissue on one side of the prolapsed organ, followed by establishing a second pathway in tissue on the contralateral side of the prolapsed organ. A support member, which includes a central support portion and two end portions, is positioned in a position to reposition said prolapsed organ in said organ&#39;s anatomically correct location. The end portions of the support member are introduced through the respective tissue pathways, followed by adjustment of the end portions so that the support member is located in a therapeutic relationship to the prolapsed organ that is to be supported. An apparatus and kit for said treatment is further provided.

BACKGROUND OF THE INVENTION

1. Field of the Invention

Urogenital Surgery

2. Description of the Related Art

Female genital prolapse has long plagued women. It is estimated by theU.S. National Center for Health Statistics that 247,000 operations forgenital prolapse were performed in 1998. With the increasing age of theU.S. population, these problems will likely assume additionalimportance.

Vaginal prolapse develops when intra-abdominal pressure pushes thevagina outside the body. In a normal situation, the levator ani musclesclose the pelvic floor. This results in little force being applied tothe fascia and ligaments that support the genital organs. Increases inabdominal pressure, failure of the muscles to keep the pelvic floorclosed, and damage to the ligaments and fascia all contribute to thedevelopment of prolapse. In addition, if a woman has a hysterectomy, thevaginal angle may be altered, causing increased pressure at a more acuteangle, accelerating the prolapse.

There are generally two different types of tissue that make up thesupportive structure of the vagina and uterus. First, there are fibrousconnective tissues that attach these organs to the pelvic walls(cardinal and uterosacral ligaments; pubocervical and rectovaginalfascia). Second, the levator ani muscles close the pelvic floor so theorgans can rest on the muscular shelf thereby provided. It is whendamage to the muscles open the pelvic floor or during the trauma ofchildbirth that the fascia and ligaments are strained. Breaks in thefascia allow the wall of the vagina or cervix to prolapse downward.

Several factors have been implicated as being involved in genitalprolapse in women. It is thought that individual women have differinginherent strength of the relevant connective tissue. Further, loss ofconnective tissue strength might be associated with damage atchildbirth, deterioration with age, poor collagen repair mechanisms, andpoor nutrition. Loss of muscle strength might be associated withneuromuscular damage during childbirth, neural damage from chronicstraining, and metabolic diseases that affect muscle function. Otherfactors involved in prolapse include increased loads on the supportivesystem, as seen in prolonged lifting or chronic coughing from chronicpulmonary disease, or some disturbance in the balance of the structuralsupport of the genital organs. Obesity, constipation, and a history ofhysterectomy have also been implicated as possible factors.

The common clinical symptoms of vaginal prolapse are related to the factthat, following hysterectomy, the vagina is inappropriately serving therole of a structural layer between intra-abdominal pressure andatmospheric pressure. This pressure differential puts tension on thesupporting structures of the vagina, causing a “dragging feeling” wherethe tissues connect to the pelvic wall or a sacral backache due totraction on the uterosacral ligaments. Exposure of the moist vaginalwalls leads to a feeling of perineal wetness and can lead to ulcerationof the exposed vaginal wall. Vaginal prolapse may also result in loss ofurethral support due to displacement of the normal structuralrelationship, resulting in stress urinary incontinence. Certaindisruptions of the normal structural relationships can result in urinaryretention, as well. Stretching of the bladder base is associated withvaginal prolapse and can result in complaints of increased urinaryurgency and frequency. Other symptoms, such as anal incontinence andrelated bowel symptoms, and sexual dysfunction are also frequently seenwith vaginal prolapse.

Anterior vaginal wall prolapse causes the vaginal wall to fail to holdthe bladder in place. This condition, in which the bladder sags or dropsinto the vagina, is termed a cystocele. There are two types of cystocelecaused by anterior vaginal wall prolapse. Paravaginal defect is causedby weakness in the lateral supports (pubourethral ligaments andattachment of the bladder to the endopelvic fascia); central defect iscaused by weakness in the central supports. There may also be atransverse defect, causing cystecele across the vagina.

Posterior vaginal wall prolapse results in descent of the rectum intothe vagina, often termed a rectocele, or the presence of small intestinein a hernia sac between the rectum and vagina, called an enterocele.Broadly, there are four types based on suspected etiology. Congenitalenteroceles are thought to occur because of failure of fusion orreopening of the fused peritoneal leaves down to the perineal body.Posthysterectomy vault prolapses may be “pulsion” types that are causedby pushing with increased intra-abdominal pressure. They may occurbecause of failure to reapproximate the superior aspects of thepubocervical fascia and the rectovaginal fascia at the time of surgery.Enteroceles that are associated with cystocele and rectocele may be from“traction” or pulling down of the vaginal vault by the prolapsingorgans. Finally, iatrogenic prolapses may occur after a surgicalprocedure that changes the vaginal axis, such as certain surgicalprocedures for treatment of incontinence. With regard to rectoceles, lowrectoceles may result from disruption of connective tissue supports inthe distal posterior vaginal wall, perineal membrane, and perineal body.Mid-vaginal and high rectoceles may result from loss of lateral supportsor defects in the rectovaginal septum. High rectoceles may result fromloss of apical vaginal supports. Posterior or posthysterectomyenteroceles may accompany rectoceles.

As noted, vaginal prolapse and the concomitant anterior cystocele canlead to discomfort, urinary incontinence, and incomplete emptying of thebladder. Posterior vaginal prolapse may additionally cause defecatoryproblems, such as tenesmus and constipation.

Many techniques have been tried to correct or ameliorate the prolapseand its symptoms, with varying degrees of success. Nonsurgical treatmentof prolapse involves measures to improve the factors associated withprolapse, including treating chronic cough, obesity, and constipation.Other nonsurgical treatments may include pelvic muscles exercises orsupplementation with estrogen. These therapies may alleviate symptomsand prevent worsening, but the actual hernia will remain. Vaginalpessaries are the primary type of nonsurgical treatment, but there canbe complications due to vaginal wall ulceration.

There are a variety of known surgical techniques for the treatment ofanterior vaginal prolapses. In the small proportion of cases in whichthe prolapse is caused by a central defect, anterior colporrapphy is anoption. This surgery involves a transvaginal approach in which plicationsutures are used to reapproximate the attenuated tissue across themidline of the vagina. More commonly, the prolapse is due to a lateraldefect or a combination of lateral and central defects. In theseinstances, several surgical techniques have been used, such as acombination of an anterior colporrapphy and a site-specific paravaginalrepair. Both abdominal and vaginal approaches are utilized. Biologicalor synthetic grafts have been incorporated to augment repair.

Likewise, the treatment of posterior vaginal prolapses may vary. Ifsymptoms are minimal, nonoperative therapy such as changes inactivities, treatment of constipation, and Kegel exercises might beappropriate. Again, both vaginal and abdominal approaches are used,involving sutures to reapproximate the attenuated tissue and possibly abiological or synthetic graft to augment the repair.

Sacral colpopexy entails attaching vaginal vault to the sacrum by use ofmesh or fascia. The surgery may be performed through an abdominalincision or laparoscopically. Complications include mesh infection, mesherosion, bowel obstruction, and hemorrhage from the presacral venouscomplex. If synthetic mesh is used, it is typically carefully customizedor assembled into a special shape by the surgeon. Sacral colpopexy canbe a tedious, challenging surgical procedure, with an average procedurelength of 247 minutes reported in Winters et al, Abdominal SacralColpopexy and Abdominal Enterocele Repair in the Management of VaginalVault Prolapse, Urology 56 (Suppl 6A) (2000): 55-63. Some of this timeis attributed to the time required for the surgeon to fashion theimplant. In addition, it is often required to correct multiple pelvicfloor abnormalities simultaneously, further increasing surgical time.

Sacrospinous fixation is also used to treat vaginal vault prolapse. Thisprocedure involves attaching the vaginal vault to the sacrospinousligament. This procedure requires specialized skills and has the furtherdisadvantage of tending to place the vagina in an artificial anatomicalposition.

Synthetic implants have been used to address pelvic organ prolapse andincontinence. Treatment of vaginal prolapse and treatment ofincontinence are related in many ways. The two conditions are oftenassociated with one another. Interestingly, relief of pelvic organprolapse often results in incontinence in the patient.

Various sling procedures have been used. Commonly, a sling procedure iscombined with an anterior colporhapphy. A sling procedure is a surgicalmethod involving the placement of a sling to stabilize or support thebladder neck or urethra. There are a variety of different slingprocedures. Slings used for pubovaginal procedures differ in the type ofmaterial and anchoring methods. In some cases, the sling is placed underthe bladder neck and secured via suspension sutures to a point ofattachment (e.g. bone) through an abdominal and/or vaginal incision.Examples of sling procedures are disclosed in U.S. Pat. Nos. 5,112,344;5,611,515; 5,842,478; 5,860,425; 5,899,909; 6,039,686, 6,042,534 and6,110,101.

Although serious complications associated with sling procedures areinfrequent, they do occur. Complications include urethral obstruction,development of de novo urge incontinence, hemorrhage, prolonged urinaryretention, infection, and damage to surrounding tissue and slingerosion.

The TVT Tension-free Vaginal Tape procedure utilizes a Prolene™nonabsorbable, polypropylene mesh to treat incontinence. A plasticsheath surrounds the mesh and is used to insert the mesh. Abdominal andvaginal incisions are made, followed by implantation of the mesh usingtwo curved, needle-like elements to push the mesh through the vaginalincision and into the paraurethral space. Using the procedure describedelsewhere, the mesh is looped beneath the bladder neck or urethra. Thesling is positioned to provide appropriate support to the bladder neckor urethra. When the TVT mesh is properly positioned, the cross sectionof the mesh should be substantially flat. In this condition, the edgesof the mesh do not significantly damage tissue.

Complications associated with the TVT procedure and other known slingprocedures include injury to blood vessels of the pelvic sidewall andabdominal wall, hematomas, urinary retention, and bladder and bowelinjury due to passage of large needles. One serious disadvantage of theTVT procedure, particularly for surgeons unfamiliar with the surgicalmethod, is the lack of information concerning the precise location ofthe needle tip relative to adjacent pelvic anatomy. If the needle tip isallowed to accidentally pass across the surface of any blood vessel,lymphatic duct, nerve, nerve bundle or organ, serious complications canarise. These shortcomings, attempts to address these shortcomings andother problems associated with the TVT procedure are disclosed in PCTpublication nos. PCT WO 00/74613 and PCT WO 00/74594.

Additional problems are associated with the TVT and other slingprocedures. Due to the tough fibrous nature of fascia and muscletissues, forceps or similar instruments are needed to withdraw theneedles through the abdominal wall. However, the smooth surface of theneedles, which facilitates insertion through the tissues, preventssecure attachment of the forceps onto the needles, causing slippage ordetachment of the forceps during the withdrawal procedure. Improperplacement of the TVT mesh is also particularly troublesome. If the meshis too loosely associated with its intended physiological environment,the mesh may be ineffective in supporting the urethra and treatingincontinence. Several complications can arise from a mesh that is tootightly placed including retention, sling erosion and other damage tosurrounding tissue such as the urethra and vagina. Surgeons mayexacerbate these problems by improperly attempting to adjust the tensionof a sling. If insufficient adjustment force is applied, the sling willsimply exhibit a memory property and return to its original,unacceptable position. As a result, surgeons are tempted to use a greatdeal of force in order to loosen a sling that is perceived to be tootightly associated with its intended physiological environment. Ifexcessive force is applied, the mesh will plastically deform and thecross section of the mesh will become arcuate. Excessive deformation mayresult in a lack of efficacy or, even worse, the edges of the mesh maycurl up and present a relatively sharp, frayed surface. In this curledor deformed state, the edges of the TVT mesh present sharp surfaces thatcan readily abrade or otherwise damage adjacent tissue such as theurethra, bladder or vagina. The problems associated with the TVT meshdevice are commonly seen in other similar sling or synthetic implantdevices.

U.S. Pat. No. 6,695,855 (Gaston) describes a device for treating aprolapse by vaginal suspension. The device includes an elongate,flexible pierced material, a suture connected to the material, and asuture needle joined to the suture. The device is long enough to enableposterior suspension of the vagina at the front part of the sacrum. Theother end of the device includes a distal portion having a width suchthat it can cover at least a large part of the posterior part of thevagina, a rounded cut-out with dimensions that enable it to be engagedaround the base of the vagina on at least a large part of the lower halfof the wall of the vagina. The suture is connected to the article sothat it is offset sidewise in relation to the cut-out.

PCT Publication No. WO 00/27304 (Ory) discloses a suspension device fortreating prolapse and urinary incontinence. The device comprises atleast one filiform suspension cord with limited elasticity and at leasttwo anchoring parts linked to the ends of the cord.

U.S. Pat. No. 5,112,344 and PCT Publication No. PCT/US02/32284 disclosesurgical devices for female pelvic health procedures. The IVS Tunnellerdevice (available from U.S. Surgical, Norwalk, Conn.) comprises a fixeddelta wing handle, a hollow metal tube, and a stylet that is placeablewithin the tube. The stylet has a rounded plastic tip on one end and aneyelet on the other end. The device may be used to implant apolypropylene tape for infracoccygeal sacropexy and other surgicalprocedures.

A single rigid, hollow, metal tube is associated with the IVS Tunnellerdevice. This tube passes through two separate regions of the patient'sbody with the attendant risk of cross-contamination. The outer diameteris also relatively large (about 0.25 inches) with the attendant risk oftissue damage due to such large diameter.

The polypropylene tape supplied with the IVS Tunneller is of a thin,rectangular shape and approximately 8 mm by 350 mm. This tape is notbelieved to be optimally sized and shaped to afford concomitantprocedures such as enterocele, cystocele, and or rectocele repairs. Thetape is also largely inextensible. It is highly resistant to elongationunder a longitudinal force. Such inextensibility is believed to beassociated with higher risk of tissue erosion and failure.

There is a desire to obtain a minimally invasive yet highly effectivedevice and method that can be used to treat pelvic organ prolapse withminimal to no side effects. Such a device should reduce the complexityof the currently available procedures, be biocompatible, adjustable, andnon-toxic. The treatment methods using the device should reduce pain,operative risks, infections and post operative hospital stays. Further,the method of treatment should also improve the quality of life forpatients.

SUMMARY OF THE INVENTION

The present invention is directed to a method and apparatus for treatingpelvic organ prolapse, and a kit containing elements for practicing thesame. The present invention includes a support member less susceptibleto deformation, relative to the prior art, following implantation and ameans for repositioning and adjusting the support member which does notsubject the sling to deformation pressures. The method of treatment isone that allows the operator to know the location of the instruments, asfinal passage of the needle is aided by the operator's use of hisfinger, making the method less risky for the patient. The apparatus andmethod is convenient for the operator, in that the apparatus isrelatively simple to operate and contained within the described kit. Thesling portion is relatively extensible compared to the prior art. Theneedle is of a small diameter to reduce the risk of trauma.

The method for repairing pelvic organ prolapse in a patient generallyincludes the steps of establishing a first pathway between the externalperirectal region of the patient and the region of the ischial spinespace in tissue on one side of the prolapsed organ, and establishing asecond pathway in tissue on the contralateral side of the prolapsedorgan. A support member including a central support portion and two endportions is positioned beneath the prolapsed organ in such a way as toallow repositioning of the organ into its anatomically appropriatelocation. The end portions of the support member are introduced throughthe respective tissue pathways. The end portions are adjusted so thatthe support member is located in a therapeutic relationship to theprolapsed organ that is to be supported.

In one embodiment of the invention, the method is directed to treatmentof posterior vaginal prolapse. In other embodiments, the method isdirected to treatment of vaginal vault prolapse, enterocele, rectocele,or a combination of more than one of these conditions. In anotherembodiment, the step of establishing the two tissue pathways between theexternal perirectal region and the region of the ischial spine of thepatient, includes the steps of making a midline incision across thevagina to create access to the region of the ischial spine, throughsharp and blunt dissection, and making an incision lateral and posteriorto the rectum in the skin of a buttocks. A needle is passed from theincision lateral and posterior to the rectum toward the vaginalincision. The tip of the needle is palpated distal and inferior to theischial spine and then passed through the coccygeous muscle. This stepis performed on a first side, then on the contralateral side.

Further, in another embodiment, the step of positioning a support memberin a position to support the prolapsed organ in its anatomically correctposition includes the step of connecting the support member to the tipof the passed needle, as disclosed in U.S. Pat. No. 6,652,450, which isincorporated by reference. The step of introducing the end portionsthrough the tissue pathways includes the step of retracting back throughthe respective pathways a needle to which the end portions have beenconnected. The step of adjusting the end portions so that the supportmember is in a therapeutic relationship to the prolapsed vagina that isto be supported further includes the steps of attaching the supportmember to the vaginal wall with sutures, ensuring the vaginal vault isin an appropriate anatomical position, and adjusting the support memberby manipulation of the end portions.

The present invention further provides an apparatus for treatment ofpelvic organ prolapse. The apparatus broadly includes a support portionwith two ends, for placement in a therapeutically effective position,and two elongated end portions connected respectively to each end of thesupport portion.

In one embodiment of the invention, the apparatus includes repositioningmeans for effecting tightening or loosening of the apparatus withoutadversely affecting its therapeutic efficacy. According to anembodiment, the repositioning means includes at least one filamentthreaded along at least one end portion. The repositioning means mayinclude at least one removable plastic sheath on at least one endportion, wherein the sheath is configured to affect tightening of theapparatus when the apparatus is partially implanted and the sheath isremoved.

In one embodiment, the support portion of the apparatus is substantiallyrectangular, with two long sides and two short sides. The end portionsare connected to the first and second long sides, respectively.

In another embodiment, the apparatus is substantially one tape, in whichthe support portion is a wider center section, relative to the two endportions, in which the support portion and the end portions aresubstantially one tape. Such an embodiment would allow for easier andmore secure suture attachment.

In another embodiment, the support portion is of a different material inorder to provide for better suture retention.

In another embodiment, the support portion of the apparatus includesfirst and second elongated portions and means for inserting and securinga biological graft material between the first and second elongatedportions.

In another embodiment, the support portion of the apparatus is made froma polypropylene monofilament mesh. At least one of the end portions ismade from a polypropylene monofilament mesh according to one embodiment.

In one embodiment, at least one of the end portions of the supportmember includes a connector configured to attach securely with the endof the needle.

The present invention also provides a kit including the elements forpractice of the present method. The kit broadly includes a means forrepositioning and supporting the prolapsed organ in a physiologicallycorrect position and a means for attaching said repositioning andsupporting means to an appropriate anatomical structure.

In another embodiment, the kit of the present invention includes asupport member including a support portion and two end portions, whereinat least one end portion includes a removable plastic sheath, first andsecond needles configured to atraumatically form first and secondpathways through tissue adjacent to the prolapsed organ, respectively,and handles for directing the needles.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete appreciation of the invention and many of the attendantadvantages thereof will be readily obtained as the same becomes betterunderstood by reference to the following detailed description whenconsidered in connection with the accompanying drawings, wherein:

FIG. 1 is a top view of a needle with a handle;

FIG. 2 is a side perspective of a needle with a handle;

FIG. 3 is another top view of a needle with a handle;

FIG. 4 is a perspective view of the support member combined with asheath and a dilator;

FIG. 5 is a side view of the support member showing a filament tensioncontrol member;

FIG. 6 is a top view of an embodiment of the support member showing afilament tension control member;

FIG. 7 is a side perspective of the support member combined with asheath and a dilator.

FIGS. 8 through 19 illustrate the mechanism for attaching a biologicalgraft to the present invention.

FIG. 20 illustrates the positioning of external incisions on the rectumof the patient.

FIG. 21 illustrates a method of inserting the needle in a patient.

FIG. 22 illustrates palpation to aid passage of the needle to itsappropriate position.

FIG. 23 illustrates an embodiment of the connector on the end portion ofthe mesh.

FIG. 24 illustrates positioning of the mesh by manipulating the sheathedend portions.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings, wherein like reference numerals designateidentical or corresponding parts throughout the several views. Thefollowing description is meant to be illustrative only and not limiting.Other embodiments of this invention will be apparent to those ofordinary skill in the art in view of this description.

Two tissue pathways are established between the external perirectalregion and the region of the ischial spine of the patient. Thesepathways are made by making incisions in the rectal area and the vaginalapex and passing a needle through the rectal area incision toward thevaginal incision. Referring now to the drawings, wherein like referencenumerals designate identical or corresponding parts throughout theseveral views, FIG. 1 shows a needle 14 and handle 10 suitable for usein the present invention. The handle 10 can be any suitable handle knownin the art. U.S. Pat. No. 6,652,450, hereby incorporated by reference inits entirety, discloses several possible configurations. The needle 14is generally curved or arcuate. A variety of needle designs and/orconfigurations may be used including, without limitation, straight,bent, curved, arc-shaped, Stamey, Raz and other configurations, allreferences hereinafter will be made to an arc-shaped needle in thespirit of brevity and reader convenience. Further, U.S. Pat. No.6,652,450 discloses multiple acceptable configurations, and is herebyincorporated by reference.

Overall, the shape of the needle 14 should facilitate and providecontrolled passage of the needle 14 through tissue as required. The endsor tip of the needle 14 are generally not sharpened, but may be taperedto afford easy passage through tissue while providing a blunt surfacethat avoids cutting sensitive tissue such as the bowel. It is preferredthat the diameter of the needle 14 be small relative to the prior art toreduce tissue trauma.

The needle 14 is made of a malleable, yet durable, biocompatablesurgical instrument materials such as, but not limited to, stainlesssteel, titanium, Nitinol, polymers, plastics and other materials,including combinations of materials. The needle 14 should havesufficient structural integrity to withstand the various forces (e.g.forces caused by dilator attachment, cystoscopy aid passage, andpenetration/passage of the needle 14 through the various tissues)without undergoing any significant structural deformation. Optionally,the needles 14 could be sufficiently malleable to allow a practitioneror user of the device to modify the needle 14 to a desired shape and,thereby, optimize the procedural approach.

FIG. 1 shows a needle tip 15. The needle tip is optionally adapted toconnect securely to a connector on the end of a sheath associated withat least one of the end portions of the support member. Many differentconfigurations of such a system are known in the art and within thescope of the present invention. Several are disclosed in U.S. Pat. No.6,652,450, which is incorporated by reference.

Following passage through the pathways, the needle tip is connected to asupport member of the present invention. Following proper positioning ofthe support member, the needles are retracted back through the skinincision, carrying the end portions of the support member to the skinincision. FIG. 6 shows an embodiment of the support member of thepresent invention. The support member is a mesh tape including thesupport portion 22 and two end portions 32. In various embodiments ofthe invention, the support member may be a one piece mesh with thesupport portion substantially continuous with the end portions. In theillustrated embodiment of FIG. 6, the support portion is a largersubstantially rectangular mesh that is provided pre-attached to thetape.

Many different types of mesh are known in the art and may be suitablefor the present invention. Both biocompatible absorbable andnon-absorbable yarns can be used to make the surgical meshes required.Suitable non-absorbable materials for use in the present inventioninclude, but are not limited to, cotton, linen, silk, polyamides(polyhexamethylene adipamide (nylon 66), polyhexamethylene sebacamide(nylon 610), polycapramide (nylon 6), polydodecanamide (nylon 12) andpolyhexamethylene isophthalamide (nylon 61) copolymers and blendsthereof), polyesters (e.g. polyethylene terephthalate, polybutylterephthalate, copolymers and blends thereof), fluoropolymers (e.g.polytetrafluoroethylene and polyvinylidene fluoride) polyolefins (e.g.polypropylene including isotactic and syndiotactic polypropylene andblends thereof, as well as, blends composed predominately of isotacticor syndiotactic polypropylene blended with heterotactic polypropylene(such as are described in U.S. Pat. No. 4,557,264 issued Dec. 10, 1985assigned to Ethicon, Inc. hereby incorporated by reference) andpolyethylene (such as is described in U.S. Pat. No. 4,557,264 issuedDec. 10, 1985 assigned to Ethicon, Inc. hereby incorporated byreference)) and combinations thereof

Suitable absorbable materials for use as yarns include but are notlimited to aliphatic polyesters which include but are not limited tohomopolymers and copolymers of lactide (which includes lactic acid d-,1-and meso lactide), glycolide (including glycolicacid),.epsilon.-caprolactone, p-dioxanone (1,4-dioxan-2-one),trimethylene carbonate (1,3-dioxan-2-one), alkyl derivatives oftrimethylene carbonate, delta.-valerolactone, .beta.-butyrolactone,.gamma.-butyrolactone, .epsilon.-decalactone, hydroxybutyrate,hydroxyvalerate, 1,4-dioxepan-2-one (including its dimer1,5,8,12-tetraoxacyclotetradecane-7,14-dione), 1,5-dioxepan-2-one,6,6-dimethyl-1,4-dioxan-2-one and polymer blends thereof.

In the present invention, the mesh is preferably fabricated from a 4.0mil diameter monofilament polypropylene yarn by employing methods knownin the art and described in “Warp Knitting Production” by Dr. S. Raz,Melliand Textilberichte GmbH, Rohrbacher Str. 76, D-6900Heidelberg,Germany (1987), the contents of which are incorporated by referenceherein. U.S. Pat. No. 6,638,284 is also herein incorporated by referencein its entirety.

A preferred mesh for use in the present invention is a polypropylenemesh possessing a thickness of about 0.021 inches, has about 27.5courses per inch, and 13 wales per inch. It has three bar warp knitconstruction with a bar pattern set-up of #1: 1/0, 2/3, 2/1, 2/3, 1/0,1/2, 1/0, 1/2: #2: 1/0, 2/3, 2/3, 1/0: #3: 2/3, 1/0, 1/2, 1/0, 2/3, 2/1,2/3, 2/1.

In an embodiment, the apparatus of the present invention can havedifferent mesh knits in the support member and the end portions. Such aconstruction would allow use of the optimum knit for support oranchoring. Such an apparatus could be manufactured by use of variableknitting and/or variable heat-setting techniques.

FIG. 6 also illustrates the tension control member. The tension controlmember serves as a repositioning means to effect tightening or looseningof the apparatus without adversely affecting the therapeutic efficacy ofthe apparatus.

Several different embodiments of tension adjustment member are withinthe scope of the present invention. In the illustrated embodiment, atension control member is a monofilament fiber woven into the supportmember and attached to the support member via attachment points 27located near the support portion 22 of the support member.

Other attachment configurations for the tension control member are alsoincluded within the scope of the claimed invention. Several variationsof the tension control member are described in U.S. Pat. No. 6,652,450,which is incorporated by reference in its entirety.

The tension control member enables surgeons to easily tighten or loosenthe support member tension during the surgical procedure. To reduce thetension of the support member using the tension control member, thesurgeon contacts the support member and tension control member adjacentthe prolapsed organ and pulls away from the organ. The tension of thecentral portion may be increased by grasping the support member andtension control member above the vaginal incision and pulling upward.One or both end portions of the support member and tension controlmember may be grasped to increase the tension of the support member,effecting tightening by pulling the end portions out at the incisions inthe buttocks. Affording adjustment of the support member facilitatesproper support member placement and helps avoid complications such asrecurrence and tissue erosion arising out of improper placement.

The individual fibers or filaments comprising the tension control membermay be extruded, woven, braided, spun, knitted, non-woven or have othersimilar configurations. Tension control member properties, such astensile strength, elongation at break point, stiffness, surface finish,etc., may be similar to or different from those of the support memberand may vary along the length of the support member.

FIGS. 4 and 7 show a mesh/sheath assembly. In this preferred embodiment,the end portions 32 of the support member are substantially enclosed bya sheath 34. The sheath acts to ease the passage of the mesh endportions 32 through the tissue and to protect the mesh from deformation.The sheath 34 further serves to maintain the mesh in a more sterilecondition because, prior to removal of the sheath, the mesh itself hasnot contacted the vagina. The sheath 34 further provides a means ofadjusting the positioning of the support member through manualmanipulation of the sheath 34 before their removal. The sheath 34 mayoptionally further comprise a connecting mechanism to affect a secureattachment to the end of the needle. Such mechanism may be one of manydifferent configurations known in the art, such as those keyingconfigurations disclosed in U.S. Pat. No. 6,652,450, which isincorporated by reference. A preferred embodiment comprises a loop forattachment of the end portions to the needle. This loop is enlarged toallow a surgeon to place his finger through the loop and push theconnector onto the needle.

Numerous modifications and variations of the present invention arepossible in light of the above teachings. It is understood that withinthe scope of the appended claims, the invention may be practiced otherthan as specifically described herein.

EXAMPLE OF METHOD

While many methods are contemplated herein, an example use of the methodand apparatus of treating pelvic organ prolapse is disclosed, referringto FIGS. 9 through 25.

The procedure can be carried out under local or general anesthesia. Anincision is made midline across the vaginal apex with shapr and bluntdissection to the ischial spine. Two small incisions are also made inthe skin of the buttocks. Needles are passed from perianal skinincisions in the buttocks to the vaginal incision. The needle tip ispalpated distal and inferior to the ischial spine prior to passagethrough the coccygeus muscle. Further dissection may be desired to aidpalpation of the needle passage. Connectors are connected to each needleend. Needles are retracted and mesh is positioned. The mesh is thenattached to the vaginal vault, tensioned, and the incisions are closed.

One embodiment of the present invention is a sterile, single use productconsisting of two stainless steel curved needles and a polypropylenemesh implant. The same polypropylene mesh is available in an alternativeconfiguration that allows the attachment of biological material.

Locking connectors on the ends of the mesh attach to each needle tip andare used to hold the mesh secure to the needle during passage of themesh through the body. Once snapped onto the needle tip, the connectorscannot be removed.

Three main preferred embodiments of the present apparatus are hereindescribed. The physician may decide at his/her discretion whichconfiguration is most appropriate for a particular patient.

A first embodiment (described herein as the tape embodiment) includesone-piece self-fixating mesh, two removable plastic insertion sheathsover the mesh, and two locking connectors attached to the insertionsheaths. The tape is knitted polypropylene monofilament mesh that ispre-cut to 1.1 cm width×50 cm length with a non-absorbable or absorbabletensioning suture (polypropylene) threaded through the length to allowfor tensioning adjustment after placement. The sheath affords convenienttravel of the mesh through the tissue. Finger loops are formed by thesheath to allow for easy attachment of the connectors to the needletips. The synthetic mesh tape is intended to remain in the body as apermanent implant.

A second embodiment (described herein as the cape embodiment) adds a 4cm×13 cm mesh to the tape. This soft knitted mesh has large pores and isalso made of polypropylene. The mesh is pre-attached to the tape and canbe trimmed to suit surgical preference.

A third embodiment (described herein as the bio-cape embodiment)consists of two separate 1.1 cm×22 cm polypropylene mesh pieces, usingthe same material as in the tape version. However, one end has a lockingconnector and finger loop and the other end has a plastic clamp attachedto a Y-shaped mesh used to facilitate attachment to a biologicalimplant. The clamp is designed to facilitate the attachment of graftmaterial with sutures

In order to use the present invention in treatment of pelvic organprolapse, the patient should initially be prepared by placing thepatient in a modified dorsal lithotomy position with hips flexed, legselevated in stirrups, and buttocks even with the edge of the table.Vaginal retraction may be used, if desired. Palpate the location of theischial spines.

The various embodiments require differing product preparations. If thetape embodiment is selected, no further preparation is required. If thecape embodiment is selected, trim the rectangular mesh attachment to thedesired size and shape. If the bio-cape embodiment is selected, severalsteps are required to prepare the product. First, remove the biologicalgraft from its package and prepare it as needed. Second, trim thebiological graft to the desired size and shape. Third, squeeze the clampto separate the mesh tape, as shown in FIG. 8. Fourth, insert graftmaterial into open clamp using printed marks on the device as guides tothe center of the graft, as shown in FIG. 9. Fifth, release clamp tosecure the graft material, as shown in FIG. 10. Sixth, with desiredsuture, pass up through the clamp, as shown in FIGS. 11 and 12. Seventh,pass suture down through the clamp, as shown in FIG. 13. Eighth, securethe passed sutures using the surgeon's knot(s) of choice, makingadditional throws if needed, as shown in FIGS. 14 and 15. Ninth, cutclamp sutures by passing scissors or scalpel down each side of theclamp, as shown in FIGS. 16 and 17. Tenth, remove clamp. The clampattachment sutures remain with the clamp, as shown in FIG. 18. Eleventh,assess attachment of the graft material to the mesh tape. Twelfth, slideprotective sheath over mesh connection to aid deployment, as shown inFIG. 19. Repeat attachment steps on the opposite side of the graft.

Following any required preparation, the procedure is the same for allthree of the preferred embodiments:

(1) Gain access to the external vaginal vault using surgeon's preferredmethod of incision and dissection. If the cape is used, completerectovaginal dissection is required.

(2) Make two small stab incisions on each side of the rectumapproximately 3 cm lateral and 3 cm posterior to the anus, as shown inFIG. 20.

(3) Grasp the needle in one hand with the needle tip between the thumband forefinger. Place the other hand near the needle bend. The twoneedles are identical. Either side may be done first.

(4) Point the needle tip perpendicular to the skin with the handlepointing upward in a 12:00 position, as shown in FIG. 21.

(5) Direct the needle at a slight upward and lateral angle through thebuttock. Puncture the initial layers of tissue by pushing on the needlebend until the needle enters the ischiorectal fossa.

(6) Continue to pass the needle tip lateral and parallel to the rectumtoward the ischial spine. Palpate as needed, as shown in FIG. 22.

(7) Palpate the needle tip in front of the ischial spine. Penetrate thelevator muscle advancing and lightly turning the needle tip mediallytoward the vaginal vault.

(8) Perform digital rectal exam to verify rectal integrity.

(9) Repeat steps 3-9 on patient's contralateral side.

(10) Insert a finger into the loop behind the connector on the mesh, asshown in FIG. 23. Insert the connector into the vagina. Snap onto theneedle tip.

(11) Pull each needle and connector back through the skin incision.Adjust the sheath and mesh into an approximate position.

(12) Cut the needles from the mesh near the end of the sheath, below theblue dots provided to guide the surgeon.

(13) Attach the mesh to the exterior apex of the vaginal wall with twoor more sutures.

(14) Ensure the vaginal wall is in the appropriate anatomic position. Ifthe cape is being used, lay the cape in the perirectal space, in atension-free manner, and close the perirectal fascia over the mesh orthe vaginal incision.

(15) Pull on the mesh assemblies to make final adjustments, as shown inFIG. 24.

(16) Remove plastic sheaths.

(17) Trim the mesh at the level of the subcutaneous tissue.

(18) Close the incisions.

(19) Use vaginal pack and antibiotic prophylaxis as appropriate.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

1. A method for repair of pelvic organ prolapse in a patient, saidmethod comprising the steps of: establishing a first pathway in tissueon a first side of said prolapsed organ, said first pathway extendingbetween an external perirectal region to a region of an ischial spine ofthe patient; establishing a second pathway in tissue on a contralateralside of said prolapsed organ, said second pathway extending between anexternal perirectal region to a region of an ischial spine, and throughlevator muscle of the patient; positioning a support member in aposition to reposition said prolapsed organ in said organ's anatomicallycorrect location, said supporting member comprising a support portionhaving a first and second end, and two end portions, said end portionsrespectively attached to said first end and said second end; introducingsaid end portions through said first and second pathways, respectively;and adjusting said end portions so that said support member is in atherapeutic relationship to a tissue of said prolapsed organ that is tobe supported.
 2. The method of claim 1, wherein said pelvic organprolapse is a vaginal vault prolapse.
 3. The method of claim 1, whereinsaid pelvic organ prolapse is an enterocele.
 4. The method of claim 1,wherein said pelvic organ prolapse is a rectocele.
 5. The method ofclaim 1, wherein said pelvic organ prolapse includes more than one ofthe group consisting of vaginal vault prolapse, enterocele, andrectocele.
 6. The method of claim 2, wherein the step of establishing afirst pathway in tissue on a first side of said prolapsed organ, saidpathway extending between an external perirectal region to a region ofan ischial spine space of the patient, comprises the steps of: making amidline incision in an apex of a vagina; dissecting to a region of anischial spine; making a first incision lateral and posterior to therectum in a skin of a buttocks; passing a needle from said firstincision toward said vaginal incision; palpating a tip of said needledistal and inferior to an ischial spine; and passing said needle througha levator muscle.
 7. The method of claim 2 wherein the step ofestablishing a second pathway in tissue on a contralateral side of saidprolapsed organ, said pathway extending between an external perirectalregion to a region of an ischial spine of the patient, comprises thesteps of: making a second incision lateral and posterior to the rectumin a skin of a buttocks on the contralateral side respective to saidfirst incision; passing a needle from said second incision toward saidvaginal incision; palpating a tip of said needle distal and inferior toan ischial spine; and passing said needle through a levator muscle. 8.The method of claim 2 wherein said step of positioning a support memberin a position to reposition said prolapsed organ in said organ'sanatomically correct location, said supporting member comprising asupport portion having a first and second end, and two end portions,said end portions respectively attached to said first end and saidsecond end, comprises the step of connecting said support member to atip a needle, said needle being passed from an incision in saidpatient's external perirectal region through a tissue on a side of saidprolapsed organ through to said region of an ischial spine of thepatient to form said pathway.
 9. The method of claim 2, wherein saidstep of introducing said end portions through said first and secondpathways comprises the step of retracting back through said respectivepathways a needle to which said end portions have been connected. 10.The method of claim 2, wherein said step of adjusting said end portionsso that said support member is in a therapeutic relationship to a tissueof said prolapsed organ that is to be supported further comprises:attaching said support member to a vaginal wall with sutures; ensuring avaginal vault is in an appropriate anatomical position; and adjustingsaid support member by manipulation of said end portions.
 11. A methodof claim 1, wherein the step of establishing a first pathway in tissueon a first side of said prolapsed organ, said first pathway extendingbetween an external perirectal region to a region of an ischial spinespace of the patient, comprises: making an incision in tissue of avagina; dissecting to a region of an ischial spine; making a firstincision lateral and posterior to the rectum in a skin of a buttocks;passing a needle from said first incision toward said vaginal incision;palpating a tip of said needle distal and inferior to an ischial spine;passing said needle through a levator muscle; engaging an end of theneedle with a connector located at an end of a first end portion of thesupporting member; and removing the needle to pull the implant portionthrough the first tissue pathway.
 12. The method of claim 11 wherein thefirst end portion comprises repositioning means.
 13. A method of claim11 wherein the step of establishing a second pathway in tissue on asecond side of said prolapsed organ, said second pathway extendingbetween an external perirectal region to a region of an isehial spinespace of the patient, comprises: making an incision in tissue of avagina; dissecting to a region of an ischial spine; making a secondincision lateral and posterior to the rectum in a skin of a buttocks;passing a needle from said second incision toward said vaginal incision;palpating a tip of said needle distal and inferior to an ischial spine;passing said needle through a levator muscle; engaging an end of theneedle with a connector located at an end of a second end portion of thesupporting member; and removing the needle to pull the second endportion through the second pathway.
 14. The method of claim 13 whereinthe first and second end portions each comprise repositioning means. 15.An apparatus for treating pelvic organ prolapse in a patient comprising:a support portion for placement in a therapeutically effective position,having first and second ends; and exactly two elongated end portionsconsisting of a first elongated end portion connected to said first endof said support portion and configured to extend through a tissue pathfrom vaginal tissue, to a region of an ischial spine, and to an externalperirectal incision; and a second elongated end portion connected tosaid second end of said support portion and configured to extend througha tissue path from vaginal tissue, to a region of an ischial spine, andto an external perirectal incisions, wherein the support portioncomprises a width and the end portions comprise a width, the widthsbeing perpendicular to the elongate direction of the end portions, thewidth of the support portion being greater than the width of the endportions, and the support portion extending beyond the width of the endportions in a forward direction and in a rearward direction.
 16. Theapparatus of claim 15, further comprising a repositioning means toeffect tightening or loosening said apparatus without adverselyaffecting the therapeutic efficacy of said apparatus.
 17. The apparatusin claim 16, wherein said repositioning means comprises at least onefilament threaded along at least one end portion.
 18. The apparatus ofclaim 16, wherein said repositioning means comprises at least oneremovable sheath on at least one end portion, said sheath to affecttightening of said apparatus when the apparatus is partially implantedand said sheath is removed.
 19. The apparatus of claim 15, wherein saidsupport portion is substantially rectangular, having a first and secondlong side and two short sides, wherein said first and second endportions are connected to said first and second long sides,respectively.
 20. The apparatus of claim 15, wherein said supportportion comprises first and second elongated portions; and a means forinserting and securing a biological graft material between said firstand second elongated portions.
 21. The apparatus of claim 15, whereinsaid support portion is made from a polypropylene monofilament mesh. 22.The apparatus of claim 15, wherein said support portion is made from aknitted surgical mesh comprised of a knitted yam having a thickness ofabout 0.021 inches, having about 27.5 courses per inch, and about 13wales per inch three bar warp knit construction with a bar patternset-up of#1: 1/0, 2/3, 2/1, 2/3, 1/0, 1/2, 1/0, 1/2 #2: 1/0, 2/3, 2/3,1/0:#3: 2/3, 1/0, 1/2, 1/0, 2/3, 2/1, 2/3, 2/1.
 23. The apparatus ofclaim 15, wherein at least one of said end portions is made from apolypropylene monofilament mesh.
 24. The apparatus of claim 15, whereinat least one of said end portions is made from a knitted surgical meshcomprised of a knitted yarn having a thickness of about 0.021 inches,having about 27.5 courses per inch, and about 13 wales per inch threebar warp knit construction with a bar pattern set-up of#1: 1/0, 2/3,2/1, 2/3, 1/0, 1/2, 1/0, 1/2: #2: 1/0, 2/3, 2/3, 1/0: #3: 2/3, 1/0, 1/2,1/0, 2/3, 2/1, 2/3, 2/1.
 25. The apparatus of claim 15, wherein said endportions and said support portion are formed from differing mesh knits.26. The apparatus of claim 15, wherein said end portions and saidsupport portion are formed from differing materials.
 27. The apparatusof claim 15, wherein said support portion and said end portions aresubstantially comprised in a single article, wherein said supportportion is wider relative to said end portions.
 28. The apparatus ofclaim 15 wherein at least one of said end portions further comprises aconnector configured to attach securely with an end of a needle.
 29. Theapparatus of claim 18 wherein said removable sheath comprises a plasticsheath, and the apparatus further comprises a connector at an end ofeach end portion and configured to attach securely with an end of aneedle.
 30. A kit for repairing pelvic organ prolapse in a patientcomprising: an apparatus as recited in claim 15, wherein the apparatusis an implant, comprising a means for repositioning and supporting saidorgan in a physiologically correct position; and a means for attachingsaid repositioning and supporting means to an appropriate anatomicalstructure.
 31. A kit comprising an apparatus of claim 28 in combinationwith a needle, the needle comprising an end configured to attachsecurely to the connector.
 32. A kit comprising an apparatus of claim 29in combination with a needle, the needle comprising an end configured toattach securely to the connector.
 33. The apparatus of claim 15 whereinthe support portion has comprises a first and second long side and twoshort sides, wherein the first and second end portions are connected tosaid first and second long sides, respectively.
 34. The apparatus ofclaim 33 wherein at least one of the end portions further comprises aconnector configured to attach securely with an end of a needle.
 35. Theapparatus of claim 34 further comprising a repositioning means to effecttightening or loosening said apparatus without adversely affecting thetherapeutic efficacy of said apparatus.